Title Clinical Systems Advisor
LocationRemote
Job Information

The Clinical Systems Advisor position is a hands-on role, this person will be responsible for partnering with R&D functions (Clinical Affairs, Data Management, Statistics, Medical Affairs) to identify, design, implement and support new business capabilities.

Knowledge and Skills

  • Must have strong business analysis skills and able to quickly document complex as-is and to-be business processes using process modeling tools
  • Must have strong project management skills and have managed projects from initiation to post go-live stabilization
  • Experience implementing CTMS (Oracle eClinical, Medidata), EDC (Medidata RAVE), eTMF (Documentum, VEEVA), Safety Systems (Oracle Argus), or Reporting/Analytics (Cognos) solutions is a plus
  • Experience developing optimized and sustainable global production support models for various technology solutions
  • Good working knowledge of federal regulations including 21 CFR Part 11, with strong experience validating regulated technology solutions
  • Must possess excellent communication (oral and written) and problem-solving skills
  • Must be self-motivated, detail oriented and able to multi-task
  • Must be comfortable in a fast-paced, demanding and dynamic work environment

Work Experience

  • At least 8 years of relevant IT and/or business experience working in the biotech, pharma, medical device area, particularly within R&D
  • Must have strong knowledge of and experience using formal SDLC methodologies
  • Must have Bachelor degree in life science, computer science or related degree required
  • PMP Certification is a plus
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